II.B.1. Objectives

The PSMF shall describe the pharmacovigilance system and support/document its compliance with the requirements. As well as fulfilling the requirements for a PSMF laid down in the legislation and guidance, it shall also contribute to the appropriate planning and conduct of audits by the applicant or marketing authorisations holder(s), the fulfilment of supervisory responsibilities of the QPPV, and of inspections or other verification of compliance by national competent authorities. The PSMF provides an overview of the pharmacovigilance system, which may be requested and assessed by national competent authorities during marketing authorisation application(s) or post-authorisation.

Through the production and maintenance of the PSMF, the marketing authorisation holder and the QPPV should be able to:

• gain assurance that a pharmacovigilance system has been implemented in accordance with the requirements;
• confirm aspects of compliance in relation to the system;
• obtain information about deficiencies in the system, or non-compliance with the requirements;
• obtain information about risks or actual failure in the conduct of specific aspects of pharmacovigilance.

The use of this information should contribute to the appropriate management of and improvement(s) to the pharmacovigilance system.

The requirements for submission of a summary of the marketing authorisation holder’s pharmacovigilance system, provision of the content of PSMF and the history of changes to the relevant authority(ies) should enable the appropriate co-ordination of inspections by the Agency, and the planning and effective conduct of inspections by national competent authorities, based on a risk assessment approach.

Responsibilities, in terms of the PSMF, for marketing authorisation holders and applicants, national competent authorities and the Agency are described in detail in Section C (see II.C.1.).